Clinical laboratory · 2025
Performance Validation and Blood Donation Analysis in Nagqu, Tibet, One of the Highest Cities in the World.
СтатьяВалидационное исследованиеНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Zang Liang, Zhou Lei, Fan Yaxin, Liang Xiaohua, Duo Ji, Lin Hao, Bai Rui, Yang Mei, Dan Chao
Аннотация
BACKGROUND: Due to the unique geographical and climatic conditions in Nagqu (Tibet), the blood station laboratory was only fully established and accredited by 2020. This study validated the performance of the laboratory's blood screening system and analyzed recent trends in blood donation and screening effectiveness.
METHODS: Various serum samples were used to assess the performance of hepatitis B, hepatitis C, HIV, and syphilis tests, both serological and nucleic acid tests. Donation data were also collected and analyzed.
RESULTS: Serological testing demonstrated excellent sensitivity, specificity, and reproducibility (all 100%), with detection limits for HBsAg, HCV Ab, HIV-1 Ab, HIV-1 p24, and TP Ab of 0.2 IU/mL, 0.013 NCU/mL, 0.25 NCU/mL, 1.25 U/mL, and 1.5 mIU/mL, respectively. Nucleic acid testing systems also achieved 100% reproducibility with precision below 5%. PROBIT analysis revealed the 95% detection limits for HBV DNA, HCV RNA, and HIV-1 RNA as 8.29, 97.14, and 40.52 IU/mL, respectively. The study also found a high rate of unqualified donations for local markers such as ALT, HBsAg, syphilis, and HBV DNA.
CONCLUSIONS: The validation confirmed the screening system's high sensitivity, specificity, and reproducibility, highlighting the importance of effective predonation checks to ensure a safe blood supply in high-altitude areas.
METHODS: Various serum samples were used to assess the performance of hepatitis B, hepatitis C, HIV, and syphilis tests, both serological and nucleic acid tests. Donation data were also collected and analyzed.
RESULTS: Serological testing demonstrated excellent sensitivity, specificity, and reproducibility (all 100%), with detection limits for HBsAg, HCV Ab, HIV-1 Ab, HIV-1 p24, and TP Ab of 0.2 IU/mL, 0.013 NCU/mL, 0.25 NCU/mL, 1.25 U/mL, and 1.5 mIU/mL, respectively. Nucleic acid testing systems also achieved 100% reproducibility with precision below 5%. PROBIT analysis revealed the 95% detection limits for HBV DNA, HCV RNA, and HIV-1 RNA as 8.29, 97.14, and 40.52 IU/mL, respectively. The study also found a high rate of unqualified donations for local markers such as ALT, HBsAg, syphilis, and HBV DNA.
CONCLUSIONS: The validation confirmed the screening system's high sensitivity, specificity, and reproducibility, highlighting the importance of effective predonation checks to ensure a safe blood supply in high-altitude areas.